The Effects of Exogenous Ketones on Glucose Tolerance

Phase 1

Completed

• Conditions: Dietary Supplement: Ketone Supplement; Dietary Supplement: Placebo
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Ketone monoester

• Registration Number: NCT04088617
• Lead Sponsor: University of British Columbia

Brief Summary

The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to a high carbohydrate mixed meal in young healthy individuals.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-13
• Primary Completion: 2019-10-30
• Study Completion: 2020-01-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Young healthy individuals
• Not taking any medications affecting glucose metabolism

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Exclusion Criteria

• Competitive endurance athlete (i.e., train specifically for cycling, triathlon or distance running and compete at a high level)
• Diagnosed with the chronic medical condition that may impact consumption of carbohydrates or supplements (e.g., diabetes, heart disease)
• Are currently using medications that may interfere with insulin sensitivity
• Adhere to a strict high-fat low-carbohydrate or ketogenic diet (within the last 3 months)
• Are currently using ketone supplements
• Unable to travel to and from the university in order to make your testing appointments.
• Unable to follow the controlled diet instructions required for the study.
• If pregnant or are planning to become pregnant during the study (if female)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Acute morning dose of flavour-matched placebo.
Ketone monoester	Ketone monoester	Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)

Primary Outcome Measures

Name	Time	Method
Glucose area under the curve	2-hour	Area under the curve for glucose during high carbohydrate mixed meal tolerance test

Secondary Outcome Measures

Name	Time	Method
Free fatty acids area under the curve	2-hour	Non-esterified fatty acids area under the curve during high carbohydrate mixed meal tolerance test
2-hr glucose level	2-hour	Plasma glucose assessed 2-hr after high carbohydrate mixed meal tolerance test
Beta-hydroxybutyrate level	2-hour	Blood beta-hydroxybutyrate concentration assessed by handheld monitor
Insulin area under the curve	2-hour	Insulin area under the curve during high carbohydrate mixed meal tolerance test
Glucose incremental area under the curve	2-hour	Incremental area under the curve (above baseline) for glucose during high carbohydrate mixed meal tolerance test
Insulin incremental area under the curve	2-hour	Incremental area under the curve (above baseline) for insulin during high carbohydrate mixed meal tolerance test

Trial Locations

Locations (1)

University of British Columbia, Okanagan; 🇨🇦 Kelowna, British Columbia, Canada